Device product
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Z-1660-2022
Product summary
- Event
- Event 90692
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2451 kits of 100 tests
- Official record key
device-enforcement:Z-1660-2022
Official wording
Reason: One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Code information: UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.